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The Implications of Brexit on Aromatherapy Products Regulations
On June 23 2016, the United Kingdom held a referendum for the people to decide whether they wanted to remain in the European Union, or preferred to exit (Brexit). It was the highest turnout for a UK-wide vote and the nation held its breath until 7.00am on the 24th when it was officially announced that the vote was for ‘out’. This historic decision shocked the world and has divided the United Kingdom. The sense of uncertainty created has sent ripples around the world, and speculation is rife about the future of many aspects for businesses in the UK. There are many unanswered questions from worried manufacturers, aromatherapists and consumers who have been asking if Brexit could negatively impact on the aromatherapy industry.
While it is impossible to predict right now the long-term implications that Brexit may have on the aromatherapy industry, it will be ‘business as usual’ until the the UK government decide which of our current laws and regulations they wish to keep, and choose those they want to amend, and then finally put a plan together to achieve the changes. Approximately 60% of these laws and regulations were put in place by the EU, or are based on EU directives – so there is a tremendous amount of work to do. No doubt the process of leaving the EU will become clearer as the UK works its way through the ‘divorce’ procedure. Therefore, all of the EU regulations that apply to the manufacture and supply of essential oils, personal care and aromatherapy products and services remain exactly as they are, and suppliers are required to comply with all the EU consumer safety regulations that apply when trading in Europe. These regulations include the General Product Safety Regulation, the Cosmetic Regulations, the Weights and Measures Regulations, the Control of Hazardous Chemicals (essential oils) and the various health and safety regulations suppliers currently have to comply with in order to ensure that the products they supply are safe for the consumer to use.
Please see below a summary of the regulations of interest to aromatherapists as they apply now and what we know about the implications of Brexit:
Section 12(1) and the registration of herbalists
Section 12(1) of the 1968 medicines act, often called the ‘herbalist’s exemption’ permits herbalists and other practitioners to make and supply an unlicensed herbal remedy to their clients under specified conditions including a face to face consultation. This exemption was incorporated into the Human Medicines Regulation 2012 as Regulation 3(6) when it was revised to include the EU Traditional Herbal Medicines Directive. Since then there has been an ongoing debate on whether or not herbalists should be statutorily regulated, something supported by the Herbal Medicines professional associations representing the majority of herbalists, however it is not unanimous and the last five governments have not been able or willing to make a decision in spite of commissioning several enquiries. The last enquiry failed to support the registration of herbalists. It now looks likely that this is the end of the discussion and that the government is not going to take action especially as they are now preoccupied with Brexit. The herbal professions have not altogether given up on it and it may come back at some time in the future. At one time it was feared that if herbalists were not registered then the herbalist’s exemption would be withdrawn, but it does not appear that this is likely to happen now and so the herbalist’s exemption is available to any practitioner, including clinical aromatherapists who have traditionally relied on it.
Cosmetic Regulation (EC) No. 1223/2009 and fragrance allergens
In 2012 the EU Scientific Committee on Consumer Safety (SCCS) published a report that recommended that several severe fragrance allergens be banned in cosmetic products and several others be severely restricted, and an even larger group be included on the ingredients list on the labels of cosmetic products. Following a consultation and pressure from the industry it was clear that the European Commission (EC) was not going to implement these recommendations in full. Three severe fragrance allergens have now been banned this year but they do not affect essential oils used in aromatherapy. In 2013 the cosmetic regulation was amended (EU 344/2013) to include a specification to restrict the peroxide content of a number of essential oils derived from species of pine, fir and cypress including Pinus sylvestris (Scots Pine oil), Cedrus atlantica (cedarwood atlas oil) and Cupressus sempervirens (cypress oil) the others listed are not typically used in aromatherapy, although they are used in cosmetic products. The full list is in annex III to the amendment above. The significance of the restriction on the level of peroxides is that when substances like limonene, linalool, and the pinenes are oxidised they break down to form hydroperoxides which makes the substances and the essential oils that contain them much more sensitising. This restriction means that for the listed essential oils they can only be used in a cosmetic product if the peroxide level is less than that specified in the regulations. However, as the peroxide content of finished cosmetics is not specified by the regulation there is no way of knowing if the manufacturers are adhering to this restriction or not. This is an issue that is currently being investigated with a view to possibly including a maximum peroxide level in finished cosmetic products at some time in the future. There is no indication whether the EC intends to implement the other parts of the SCCS opinion and if so when.
NB. If you make and sell creams, lotions etc. and sell them to the general public without them receiving a treatment, you are classified as a manufacturer. Currently, ‘Responsible Persons’ for cosmetic manufacturers and importers, register their products on the Cosmetic Products Notification Portal (CPNP). This enables the National Poisons Information Service (NPIS) to access data about the content of cosmetic products so they can advise on healthcare treatments to frontline health workers on a 24/7 basis. The portal also provides local authorities access to information about cosmetic products for market surveillance purposes.
After Brexit, the cosmetic regulations will still be enforceable in the UK because EU regulations have to be enforced, as a condition of membership of the EU, by passing a law in each member state the UK enforcement regulations will remain on the statue books until the UK removes it. At the moment we have no idea how the UK government is going to deal with the thousands of EU regulations and directives that have been enacted into UK law. The best guess is that as far as consumer safety regulations like cosmetics is concerned nothing will change in the foreseeable future and all current EU law will remain in force. In any case if aromatherapists and manufacturers of products regulated by the cosmetic regulations want to sell them in the EU they will have to comply with the EU regulations including the requirement that the ‘Responsible Person’ be based in the EU. Unless special arrangements are made, and that seems unlikely in the short term, UK based cosmetic product manufacturers will have to appoint another organisation that is based in the EU to be the ‘Responsible Person’ to take legal responsibility for those products. In a ‘no deal scenario’, a cosmetic product may not be placed on the market unless there is a Responsible Person established in the UK. UK Responsible Person accounts for those used by market surveillance authorities will be suspended or deleted from the EU’s CPNP after exit. The UK government is currently establishing a cosmetic product database to replace the CPNP in the UK.
The Product Safety and Metrology (EU Exit) Regulations 2019 statutory instrument has been laid before Parliament and seeks to ensure continuity of the legal framework for product safety in the UK. If the amendments made by the Statutory Instrument (SI) come into force, their purpose will be to provide the legal framework, including for cosmetics, that businesses will need to comply with to trade in the UK should the UK leave Europe with no deal. It will also ensure that consumers of cosmetic products continue to be protected and have the reassurance that the UK will retain an effective product safety regime. Using the new UK database will be the main practical change for businesses in complying with the new UK regime. The database will be set up to be as familiar as possible for those used to using the CPNP and to improve on current database usability, for example, by removing size limits for pictures of packaging.
General Product Safety Regulation 2005
There have been plans to revise this regulation for several years, draft regulations have been published and a consultation held and it has still not been implemented. The implication for aromatherapists is that the new regulation will include the blends that aromatherapists make and use on their clients during a massage session. Currently these blends are subject to a safety assessment under the Control Of Substances Hazardous to Health (COSHH) regulations but under the new regulations they will be general products and there will be a requirement to make a written safety assessment for every blend and keep a dossier of information similar to the product information file required by the cosmetic regulation. This will not be a problem for aromatherapists as this is already part of your normal practice. As aromatherapists who make and supply aromatherapy products to the general public know, these products, unless they meet the definition of a cosmetic product are regulated by the general product regulations. Again, this is a UK regulation based on an EU directive and is already enacted into UK law so it will continue in force in the UK whatever happens after Brexit. The new EU regulation is a regulation and not a directive so an enforcement regulation will have to be passed into UK law if the regulation is published before Brexit. If it isn’t then the current general product safety regulation will remain in force and the products that aromatherapists make and use on their clients will remain regulated by the COSHH regulation.
In summary; it is important to remember that no matter what changes the UK decides to make in the regulations for UK customers in the future, all products supplied to EU member states from the UK must continue to comply with the existing EU regulations. And it seems highly unlikely all of these are going to change any time soon! The IFA will continue to monitor events as they unfold and keep members and the general public updated with the latest information as the process of exiting the EU unfolds. In the meantime you might be interested in what the UK’s leading personal care industry trade association has to say about continued product safety on the Cosmetic, Toiletry & Perfumery Association (CTPA) website. Here’s what the European Commission has to say about the UK’s obligations whilst the UK prepares to leave the EU.
For more information
If you would like would like to discuss any of the issues raised please contact the Aromatherapy Trade Council (ATC) by visiting: www.a-t-c.org.uk or call Ray Gransby on 01673 844 672 during office hours 10am to 4pm Monday to Friday or email email@example.com.